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临床试验/NCT05974423
NCT05974423Enrolling By Invitation4 期

Prospective Randomized Trial of Narcotic vs Non-Narcotic Pain Modulation Following a Labrum Repair

The Cooper Health System1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年12月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
Enrolling By Invitation
入组人数
60
试验地点
1
主要终点
Postoperative pain control

研究概览

简要总结

The purpose of this study is to determine if patients age 15 to 30 years old being treated for shoulder labrum repair and SLAP lesions have significant differences in pain levels postoperatively when treated with a combination therapy of ibuprofen, and acetaminophen compared to oxycodone. Participants will be randomly placed into either the control arm and receive scripts for non-narcotic medications (Tylenol and Ibuprofen) and opioids, or the experimental arm of the study. receiving only a prescription for the non-narcotic medications. Every patient will receive a preoperative Exparel nerve block as is the standard of care for this procedure. Both groups will fill out a pain journal for 14 days following surgery and complete a pill count at the first postoperative visit to validate the amount of pain medication documented in the pain journal.

详细描述

The opioid crisis has illuminated the risks of opioid use for pain management, with renewed interest in reducing opioid consumption after common orthopedic procedures. Anti-inflammatory medication is an important component of multimodal pain management for patients undergoing orthopedic surgery. Several relevant studies have inquired about the use of opioid consumption in the management of total knee arthroplasty, total hip arthroplasty, total shoulder arthroplasty as well as arthroscopic shoulder surgeries. There is currently a gap in the literature, however, regarding the use of nerve blocks preoperatively in conjunction with nonopioid pharmacology postoperatively for pain. The goal is to determine if this can reduce pain levels in patients who have undergone surgical management for shoulder labrum or SLAP lesions. Hopefully, the data we can extract will allow future physicians to decrease the number of opioids prescribed and reduce the risks of prolonging the opioid epidemic.

The United States is currently in an opioid crisis. This is a public health issue that not only is limited to the United States but is echoed by countries around the world. All physicians must be accountable for the continuation of the crisis but also must be cognizant of ways to end the issue. In 2011, the United States Food and Drug Administration reported that 50 million Americans were prescribed opioids which is close to a 100 percent increase in the amount prescribed in 2008. Similarly, during that same period, opioid overdose became the leading cause of accidental death in young adults; associated with a higher risk of postoperative death, and increased risk of falls and fractures in the elderly. Many ways have been discussed to reduce the prescription of opioids such as standardized opioid prescription protocols, limits on prescription size, and restrictions on opioid use for preoperative and nonsurgical patients. Another theater of opioid use that can be addressed is that of post-operative pain management. The contribution of the potential results of our research could greatly reduce and mitigate the number of opioids prescribed postoperatively if there is no significant difference between the groups.

This will be a prospective randomized trial. Patients will be randomly placed into either the control or experimental arm of the study. Every patient will receive Exparel as is the standard of care for this procedure.

There will be two groups in this study:

  • Group 1:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between the ages of 15 - 25 years old
  • Patients with a diagnosis of a labrum tear who will undergo surgical intervention

排除标准

  • Patients under the age of 14 years old
  • Patients age 26 years or older
  • Patients with a nonoperative diagnosis of a labrum tear
  • Patients who elect not to undergo surgical treatment
  • Patients who are on opioid medications preoperatively

研究组 & 干预措施

Control - Narcotic Prescription

Active Comparator
  1. Oxycodone 5 mg 1 tablet every 6 hours PRN
  2. Tylenol 1000 mg every 8 hours
  3. Ibuprofen 600 mg every 6 hours as needed for pain

干预措施: Tylenol, Ibuprofen, and Oxycodone (Drug)

Experimental - Non-narcotic only

Experimental

This group will not be sent home with an oxycodone prescription. They will be sent home with the following prescriptions. If this does not manage their pain, they will call the resident on call who will reach out to the PI. The PI will then electronically send in a prescription of oxycodone to their pharmacy if required. The PI or operating surgeon (co-investigators) will be available 24/7 to do this. They will be sent home with these two prescriptions:

  1. Tylenol 1000 mg every 8 hours
  2. Ibuprofen 600 mg every 6 hours as needed for pain

干预措施: Tylenol and Ibuprofen only (Drug)

结局指标

主要结局

Postoperative pain control

时间窗: 2 weeks

The subjects will keep track of pain levels through a pain journal which they fill out daily and will bring to the first post-operative appointment. At their first post-operative visit, patients will also bring their pill bottles for a pill count in the office to validate the amount described in the pain journal.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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